510(k) Report

Devices descending from K982862

463 later devices reach Radworks Medical Imaging Software with Quality Control Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200704ZedViewLexi Co., Ltd.20210—
+5K200385Continuum PacsIntegrated Ophthalmic Systems, Inc.20200—
+5K200132AshvinsMedicalcommunications GmbH202001
+5K191615Huvitz Imaging SystemHuvitz Co., Ltd.20190—
+5K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+5K181345Image Filing Software NAVIS-EXNidek Co., Ltd.20181—
+5K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc.20181—
+5K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+5K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+5K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+5K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+5K162684SL 220Carl Zeiss Meditec, AG20171—
+5K163564Slit Lamp SL-2000Nidek Co., Ltd.20170—
+5K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+5K161607VisuluxCarl Zeiss Meditec, AG20170—
+5K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+5K160284JointPointJointpoint, Inc.201621—
+5K153653DICOM ViewerBrainlab AG20164—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+5K150725Visaris AvanseVisaris D.O.O. Belgrade20151—
+5K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143361Mammo WorkstationGE Healthcare20151—
+5K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+5K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+5K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG20148—
+5K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc.20140—
+5K132763Advanced ViewerBrainlab AG20141—
+5K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+5K123464Callisto EyeCarl Zeiss Meditec, AG20136—
+5K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+5K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+5K110033Feel-DRCSImfou Co., Ltd.201116—
+5K102078Radiological Image Processing SystemVATECH Co., Ltd.20116—
+5K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+5K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+5K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+5K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+5K073271OrthogonAgfa Healthcare Corporation20070—
+6K253834Visuref 600Carl Zeiss Vision GmbH20260—
+6K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+6K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+6K234076iCare ALTIUS CWCentervue S.P.A.20240—
+6K231225EConsole1DRTECH Corporation20233—
+6K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K211715RetinAI DiscoveryRetinai Medical AG20221—
+6K212720nordicDSCNordicneurolab AS20222—
+6K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+6K203651CuptimizeCuptimize, Inc.20213—
+6K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.20200—
+6K200350MyHip Planner & VerifierMedacta International S.A.20201—
+6K202519OrthoNext Platform SystemOrthofix Srl20201—
+6K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K191014Elements ViewerBrainlab AG20203—
+6K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+6K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+6K181501AfinaNeurovision Imaging, LLC20180—
+6K182464PeekMedPeek Health, S.A.201817—
+6K182376HarmonyTopcon Medical Systems, Inc.20184—
+6K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K173329jFit Surgical PlannerJointvue, LLC20170—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+6K163324nordicBrainExNordicneurolab AS20175—
+6K161937CuattroDRCuattro, LLC201601
+6K161828kneeEOSOnefit Medical20162—
+6K160937SenolrisGE Healthcare20160—
+6K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+6K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+6K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+6K152172Econsole1DRTECH Corporation20156—
+6K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+6K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+6K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+6K142671Onefit Hip PlannerOnefit Medical201410—
+6K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+6K141669SurgimapNemaris, Inc.201427—
+6K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+6K141329RadspaTelerad Tech Private Limited20140—
+6K141199Quentry Dose ReviewBrainlab AG20140—
+6K140434Medicad ClassicHectec GmbH20140—
+6K133910NordicbrainexNordicneurolab201452
+6K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+6K130278MR PermeabilityPhilips Medical Systems Nederland B.V.20131—
+6K123306Nordic TumorexNordicneurolab201301
+6K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+6K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+6K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—